3715.64
Misbranded drug or device.

(2)
It is in
package form and does not bear a label containing both of the following:

(a)
In clearly legible form, the name and
place of business of the manufacturer, packer, or distributor;

(b)
An accurate statement of the quantity of
the contents in terms of weight, measure, or numerical count; but reasonable
variations shall be permitted, and exemptions as to small packages shall apply
as established by rules adopted by the director of agriculture or state board
of pharmacy.

(3)
It is
a dangerous drug and does not bear a label containing in clearly legible form
the name and place of business of the manufacturer of the finished dosage form
and, if different, the packer or distributor.

(4)
It is a dangerous drug in finished solid
oral dosage form and it does not have clearly and prominently marked or
imprinted on it an individual symbol, company name, national drug code number
or other number, words, letters, or any combination thereof, identifying the
drug and its manufacturer or distributor. This requirement does not apply to
drugs that are compounded by a licensed pharmacist. The manufacturer or
distributor of each such drug shall make available to the state board of
pharmacy descriptive material identifying the mark or imprint used by the
manufacturer or distributor. The board shall provide this information to all
poison control centers in this state. Upon application by a manufacturer or
distributor, the board may exempt a drug from the requirements of this division
on the grounds that marking or imprinting the drug is not feasible because of
its size, texture, or other unique characteristic.

(5)
Any word, statement, or other information
that is required by or under authority of sections
3715.01 and
3715.52 to
3715.72 of the Revised Code to
appear on the label or labeling is not prominently placed on the label or
labeling in a conspicuous manner, as compared with other words, statements,
designs, or devices on the label or labeling, and in terms that render it
likely to be read and understood by the ordinary individual under customary
conditions of purchase and use.

(6)
It is a drug and it is not designated
solely by a name recognized in the United States pharmacopoeia and national
formulary, or any supplement to them, unless its label bears:

(b)
In case it is fabricated
from two or more ingredients, the common or usual name of each active
ingredient the drug contains, including the kind and quantity or proportion of
any alcohol, and also including whether active or not, the name and quantity or
proportion of any bromides, ether, chloroform, acetanalid, acetophenetidin,
aminopyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis
glycosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances; but to the extent that
compliance with these requirements is impracticable, exemptions shall apply as
established by rules adopted by the director of agriculture or state board of
pharmacy.

(a)
Adequate directions for use of the drug or device, except that when compliance
with this requirement is not necessary for a particular drug or device to
protect the public health, the director shall adopt rules exempting the drug or
device from the requirement;

(b)
Adequate warnings against use in those pathological conditions or by children
when its use may be dangerous to health, or against unsafe dosage or methods or
duration of administration or application, presented in a manner and form as
necessary for the protection of users.

(8)
It purports to be a drug the name of
which is recognized in the United States pharmacopoeia and national formulary,
or any supplement to them, and it is not packaged and labeled as prescribed in
those compendiums, except that the method of packing may be modified with the
consent of the director of agriculture. Whenever a drug is recognized in both
the homoeopathic pharmacopoeia of the United States and in the United States
pharmacopoeia and national formulary, including their supplements, it shall be
subject to the requirements of the United States pharmacopoeia and national
formulary with respect to packaging and labeling unless it is labeled and
offered for sale as a homoeopathic drug, in which case it shall be subject to
the provisions of the homoeopathic pharmacopoeia of the United States and not
to those of the United States pharmacopoeia and national formulary.

(9)
It has been found by the director of
agriculture to be a drug liable to deterioration, unless it is packaged in the
form and manner, and its label bears a statement of precautions, as required by
rules adopted by the director as necessary for the protection of public health.
No rule shall be established for any drug recognized in the United States
pharmacopoeia and national formulary, or any supplements to them, until the
director has informed the appropriate bodies charged with the revision of those
compendiums of the need for packaging or labeling requirements and those bodies
have failed within a reasonable time to prescribe such requirements.

(d)
The drug sold or dispensed is not the
brand or drug specifically prescribed or ordered or, when dispensed by a
pharmacist upon prescription, is neither the brand or drug prescribed nor a
generically equivalent drug.

(11)
It is dangerous to health when used in
the dosage, or with the frequency or duration prescribed, recommended, or
suggested in its labeling.

(12)
It
is a drug intended for human use to which the following apply:

(a)
Because of its toxicity or other
potentiality for harmful effect, the method of its use, or the collateral
measures necessary to its use, the drug is not safe for use except under the
supervision of a licensed health professional authorized to prescribe drugs;

(b)
The drug is limited by an
effective application under section 505 of the "Federal Food, Drug, and
Cosmetic Act," 52 Stat. 1040 (1938),
21 U.S.C.A.
301, as amended, to use under professional
supervision by a licensed health professional authorized to prescribe drugs,
unless it is dispensed only:

(ii)
Upon an oral prescription, which is
reduced promptly to writing by the pharmacist;

(iii)
By refilling a prescription if
refilling is authorized by the prescriber either in the original prescription
or by oral order, which is promptly reduced to writing by the pharmacist.

(B)
Any drug dispensed pursuant to a written,
electronic, or oral prescription of a licensed health professional authorized
to prescribe drugs shall be exempt from the requirements of division (A) of
this section, except divisions (A)(1) and (10) of this section, if the drug
bears a label containing the name and address of the dispenser, the serial
number and the date the prescription is dispensed, the name of the prescriber,
the name of the patient, and, if stated in the prescription, the directions for
use and cautionary statements. Unless the prescription directions prohibit
labeling, the label shall include the brand name of the drug dispensed. If the
drug dispensed has no brand name, the generic name and the distributor of the
finished dosage form shall be included.